[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-257419-105":53,"doc-detail-257419-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","quality-assurance-specialist-job-description","Quality Assurance Specialist - Job Description","","Quality Assurance Specialist role supporting the Quality Assurance Manager to achieve quality goals and measurable performance across multiple quality functions. Responsibilities include maintaining and tracking SOPs and related quality documents, managing investigation and CAPA records, assisting root-cause analysis and corrective/preventive action activities, and monitoring trends for NOEs and deviations. The role also performs audits, conducts gap analysis and quality document/process reviews, supports batch record approval for timely drug product release, and executes risk assessments for product safety and efficacy while ensuring full compliance with cGMP, regulatory, and sanitation requirements.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":16,"@type":70,"position":76},"https://docshare.wps.com/template/resumes/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/quality-assurance-specialist-job-description/257419/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/quality-assurance-specialist-job-description/257419.png","ImageObject",442,249,{"name":88,"@type":89},"Sophia Brooks","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-21","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",6,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What are the core responsibilities of a Quality Assurance Specialist?","Question",{"text":109,"@type":110},"The role supports the Quality Assurance Manager by maintaining and tracking quality-related documentation, assisting investigations and root-cause analysis, managing CAPA activities, and monitoring/trending relevant metrics.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What documentation and quality system activities does the specialist handle?",{"text":114,"@type":110},"The specialist maintains investigation and CAPA documentation, assists with corrective and preventive action work in line with the Quality System, and participates in review and approval of batch record documentation.",{"name":116,"@type":107,"acceptedAnswer":117},"What qualifications and compliance knowledge are required?",{"text":118,"@type":110},"The position requires experience in pharmaceutical manufacturing and quality assurance (with or without a degree), familiarity with GxP/FDA/ICH/OSHA, strong organizational skills, and the ability to maintain compliance with company policies, quality specifications, and cGMP practices.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},257419,1791630043,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":15,"category_name":16,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":73,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":9},962084925636,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","Quality Assurance Specialist  \nFLSA Status  \nExempt  \nJob Summary  \nThe Quality Assurance Specialist works directly with the Quality Assurance Manager and supportsand assesses operational needs and activities to successfully achieve quality goals and metrics across multiple quality functions.  \nEssential Duties and Responsibilities include the following. Other duties may be assigned.  \n• Assist in the maintenance and tracking of all Quality related documentation including, but not limited to: SOPs, Protocols, NOEs, Investigations, CAPAs, Planned Deviations, Change Controls, etc.  \n• Maintains all investigation and CAPA related documentation as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs.  \n• Assists in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the company’s Quality System.  \n• Tracks and trends appropriate metrics for open NOEs, Investigations, CAPAs, planned deviations, etc.  \n• Reports monthly metrics pertaining to NOEs, investigations, and CAPAs to Quality department management and other appropriate company personnel.  \n• Actively participate in the review and approval of batch record documentation to support quality release of drug product in a timely manner.  \n• Perform risk assessment to determine safety and efficacy of products.  \n• Assist in change control management program and document archival.  \n• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.  \n• Perform routine audits of processes and establish gap analysis.  \n• Perform quality review of documentation and processes.  \n• Assists with SOP revision and participates in inspections, as needed.  \n• Assists in other areas of QA and may cross train across department, as needed.  \nRequired Education and Experience  \n• Minimum of 6 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry without degree.  \n• Minimum of 3 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry, with degree.  \n• Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field, preferred.  \n• Familiar with GxP, FDA, ICH, and OSHA requirements.  \n• Familiar with Microsoft Office applications (Word, Excel, etc.) .  \n• Must be capable of wearing all protective wear as required. This includes, but not limited to, mask, gloves, gown, hairnet, safety goggles, etc.  \n• Must have strong organizational skills and exceptional attention to detail.  \n• Must exhibit punctuality and low absenteeism.  \n• Able to work independently and as part of a team.  \n• Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time.  \n• May need to lift up to twenty-five (25) pounds on occasion.  \nCompetencies  \n• Communication Proficiency  \n• Problem Solving/Analysis  \n• Quality  \n• Results Driven  \n• Technical Capacity  \n• Thoroughness  \nSupervisory Responsibility  \nThis position has no supervisory responsibilities.  \nWork Environment  \nThis job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking.  \nLanguage Skills  \nMust be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.  \nMathematical Skills  \nUses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.  \nReasoning Ability  \nMust have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instru","cbCaicJv16VIHSZe","https://ap.wps.com/l/cbCaicJv16VIHSZe","pdf",91696,"English","# Job Summary\n# Essential Duties and Responsibilities\n## Documentation and CAPA Management\n## Metrics, Reviews, Audits, and Risk Assessments\n# Required Education and Experience\n# Competencies and Responsibilities\n# Work Environment and Language Skills\n# Mathematical Skills and Reasoning Ability\n# Physical Demands, Hours of Work, and Travel\n# Disclaimer and AAP/EEO Statement","[{\"question\":\"What are the core responsibilities of a Quality Assurance Specialist?\",\"answer\":\"The role supports the Quality Assurance Manager by maintaining and tracking quality-related documentation, assisting investigations and root-cause analysis, managing CAPA activities, and monitoring/trending relevant metrics.\"},{\"question\":\"What documentation and quality system activities does the specialist handle?\",\"answer\":\"The specialist maintains investigation and CAPA documentation, assists with corrective and preventive action work in line with the Quality System, and participates in review and approval of batch record documentation.\"},{\"question\":\"What qualifications and compliance knowledge are required?\",\"answer\":\"The position requires experience in pharmaceutical manufacturing and quality assurance (with or without a degree), familiarity with GxP/FDA/ICH/OSHA, strong organizational skills, and the ability to maintain compliance with company policies, quality specifications, and cGMP practices.\"}]","Quality Assurance Specialist - Job Description | PDF",1789313638]